Diabetic Macular EdemaPhase 4NCT05736081
Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema
A Phase 4 study testing Intravitreal dexamethasone implant in people with Diabetic Macular Edema, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
The goal of this clinical trial es to learn about the short term effects of intravitreal dexamethasone implant (IDI) in patients with refractory diabetic macular edema. The main question it aims to answer is: How fast does the diminishing in central retinal thickness has statistical significance after IDI in patients… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Intravitreal dexamethasone implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteMexico
- Study dates
- 15 Feb 2018to 30 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with type 1 or type 2 diabetes
- diabetic macular edema involving the foveal center with CRT >300 μm measured by OCT
- at least 3 and maximum 9 monthly intravitreal injections of anti-VEGF
Who cannot join
- uncontrolled diabetes (blood glucose ≥ 250 mg/dL at any time
- previous IDI
- any condition precluding adequate fundus visualization
- uncontrolled glaucoma
- papillary excavation ≥ 0.7
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociacion Para Evitar la Ceguera en Mexico
Mexico City, Coyoacan, 04030
About this study
The goal of this clinical trial es to learn about the short term effects of intravitreal dexamethasone implant (IDI) in patients with refractory diabetic macular edema. The main question it aims to answer is:
How fast does the diminishing in central retinal thickness has statistical significance after IDI in patients with refractory diabetic macular edema? Patients will be evaluated by OCT before and after the implant.
Read the detailed description
Patients were evaluated at baseline, 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI
- Conditions
- Diabetic Macular Edema
- Being tested
- Intravitreal dexamethasone implant
- Keywords
- Diabetic macular edema, Ozurdex, Dexamethasone intravitreal implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal dexamethasone implantDrug
Also called Ozurdex implant
Intravitreal implant of dexamethasone 0.7 mg with previous topic anesthesia and iodine drops
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal dexamethasone implant | Experimental | All patients were included here and received one intravitreal dexamethasone implant 0.7mg Receives: Drug: Intravitreal dexamethasone implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in central retinal thickness
Difference among the baseline and the posterior measurements of the CRT with OCT
Measured: Prospective: from baseline to 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI
Secondary outcomes (1)
Change in Best Corrected Visual Acuity
Measurement of Best Corrected Visual Acuity before and after IDI
Measured: Prospective: from baseline to 1 month post IDI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start15 Feb 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Gerardo García Aguirre, MD, Principal investigator, Asociación para Evitar la Ceguera en México I.A.P.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736081
- Sponsor's protocol ID
- RE-20-13
- Status last verified
- Jul 2024
- First submitted
- 10 Feb 2023
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Tang J, Kern TS. Inflammation in diabetic retinopathy. Prog Retin Eye Res. 2011 Sep;30(5):343-58. doi: 10.1016/j.preteyeres.2011.05.002. Epub 2011 May 25.
PubMed 21635964Noma H, Yasuda K, Shimura M. Involvement of Cytokines in the Pathogenesis of Diabetic Macular Edema. Int J Mol Sci. 2021 Mar 26;22(7):3427. doi: 10.3390/ijms22073427.
PubMed 33810434Wallsh JO, Gallemore RP. Anti-VEGF-Resistant Retinal Diseases: A Review of the Latest Treatment Options. Cells. 2021 Apr 29;10(5):1049. doi: 10.3390/cells10051049.
PubMed 33946803Bressler SB, Ayala AR, Bressler NM, Melia M, Qin H, Ferris FL 3rd, Flaxel CJ, Friedman SM, Glassman AR, Jampol LM, Rauser ME; Diabetic Retinopathy Clinical Research Network. Persistent Macular Thickening After Ranibizumab Treatment for Diabetic Macular Edema With Vision Impairment. JAMA Ophthalmol. 2016 Mar;134(3):278-85. doi: 10.1001/jamaophthalmol.2015.5346.
PubMed 26746868Boyer DS, Yoon YH, Belfort R Jr, Bandello F, Maturi RK, Augustin AJ, Li XY, Cui H, Hashad Y, Whitcup SM; Ozurdex MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014 Oct;121(10):1904-14. doi: 10.1016/j.ophtha.2014.04.024. Epub 2014 Jun 4.
PubMed 24907062Khan Z, Kuriakose RK, Khan M, Chin EK, Almeida DR. Efficacy of the Intravitreal Sustained-Release Dexamethasone Implant for Diabetic Macular Edema Refractory to Anti-Vascular Endothelial Growth Factor Therapy: Meta-Analysis and Clinical Implications. Ophthalmic Surg Lasers Imaging Retina. 2017 Feb 1;48(2):160-166. doi: 10.3928/23258160-20170130-10.
PubMed 28195619Moreno JB, Medina DB, Rosellon-Escobar MF, Garcia-Aguirre JG. Short-term effect of intravitreal dexamethasone implant in refractory diabetic macular edema. BMC Ophthalmol. 2024 Mar 11;24(1):113. doi: 10.1186/s12886-024-03341-9.
PubMed 38462613
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT05736081
- Acronym / sponsor ID
- RE-20-13
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic macular edema, Ozurdex, Dexamethasone intravitreal implant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial es to learn about the short term effects of intravitreal dexamethasone implant (IDI) in patients with refractory diabetic macular edema. The main question it aims to answer is:
How fast does the diminishing in central retinal thickness has statistical significance after IDI in patients with refractory diabetic macular edema? Patients will be evaluated by OCT before and after the implant.
Detailed description
Patients were evaluated at baseline, 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal dexamethasone implant | Experimental | Drug: Intravitreal dexamethasone implantAll patients were included here and received one intravitreal dexamethasone implant 0.7mg |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with type 1 or type 2 diabetes
- diabetic macular edema involving the foveal center with CRT >300 μm measured by OCT
- at least 3 and maximum 9 monthly intravitreal injections of anti-VEGF
Key exclusion criteria (5 listed)
- uncontrolled diabetes (blood glucose ≥ 250 mg/dL at any time
- previous IDI
- any condition precluding adequate fundus visualization
- uncontrolled glaucoma
- papillary excavation ≥ 0.7
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal dexamethasone implantAlso: Ozurdex implantIntravitreal implant of dexamethasone 0.7 mg with previous topic anesthesia and iodine drops | Drug | Intravitreal dexamethasone implant |
Primary outcome
Change in central retinal thickness
Time frame: Prospective: from baseline to 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI
Difference among the baseline and the posterior measurements of the CRT with OCT
1 secondary outcome
Change in Best Corrected Visual Acuity
Time frame: Prospective: from baseline to 1 month post IDI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 21635964Tang J, Kern TS. Inflammation in diabetic retinopathy. Prog Retin Eye Res. 2011 Sep;30(5):343-58. doi: 10.1016/j.preteyeres.2011.05.002. Epub 2011 May 25.
- Background: PubMed 33810434Noma H, Yasuda K, Shimura M. Involvement of Cytokines in the Pathogenesis of Diabetic Macular Edema. Int J Mol Sci. 2021 Mar 26;22(7):3427. doi: 10.3390/ijms22073427.
- Background: PubMed 33946803Wallsh JO, Gallemore RP. Anti-VEGF-Resistant Retinal Diseases: A Review of the Latest Treatment Options. Cells. 2021 Apr 29;10(5):1049. doi: 10.3390/cells10051049.
- Background: PubMed 26746868Bressler SB, Ayala AR, Bressler NM, Melia M, Qin H, Ferris FL 3rd, Flaxel CJ, Friedman SM, Glassman AR, Jampol LM, Rauser ME; Diabetic Retinopathy Clinical Research Network. Persistent Macular Thickening After Ranibizumab Treatment for Diabetic Macular Edema With Vision Impairment. JAMA Ophthalmol. 2016 Mar;134(3):278-85. doi: 10.1001/jamaophthalmol.2015.5346.
- Background: PubMed 24907062Boyer DS, Yoon YH, Belfort R Jr, Bandello F, Maturi RK, Augustin AJ, Li XY, Cui H, Hashad Y, Whitcup SM; Ozurdex MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014 Oct;121(10):1904-14. doi: 10.1016/j.ophtha.2014.04.024. Epub 2014 Jun 4.
- Background: PubMed 28195619Khan Z, Kuriakose RK, Khan M, Chin EK, Almeida DR. Efficacy of the Intravitreal Sustained-Release Dexamethasone Implant for Diabetic Macular Edema Refractory to Anti-Vascular Endothelial Growth Factor Therapy: Meta-Analysis and Clinical Implications. Ophthalmic Surg Lasers Imaging Retina. 2017 Feb 1;48(2):160-166. doi: 10.3928/23258160-20170130-10.
- Derived from this study: PubMed 38462613Moreno JB, Medina DB, Rosellon-Escobar MF, Garcia-Aguirre JG. Short-term effect of intravitreal dexamethasone implant in refractory diabetic macular edema. BMC Ophthalmol. 2024 Mar 11;24(1):113. doi: 10.1186/s12886-024-03341-9.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Gerardo García Aguirre, MD principal investigator
Asociación para Evitar la Ceguera en México I.A.P.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravitreal dexamethasone implant in people with Diabetic Macular Edema, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in central retinal thickness (time frame: Prospective: from baseline to 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05736081, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.